A Metabolomics-based Study to Explore the Mechanism of Remission of Metabolic Syndrome After Radical Gastrectomy

NCT06707714 | Enrolling By Invitation DMC

• 1 other identifier: 2511756041
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Analysis of preoperative and postoperative metabolite changes: Through metabolomics technology, the changes of preoperative and postoperative metabolites in patients with gastric cancer complicated with metabolic syndrome were systematically analyzed, and the key metabolites related to the remission of hypertension, hyperlipidemia, and diabetes after surgery were found.
2. 2.Explore the influencing factors of postoperative remission of metabolic syndrome: Combined with clinical data, the association between various metabolites and the degree of postoperative remission was evaluated, and the main factors affecting postoperative remission were determined.
3. 3.Reveal the mechanism of postoperative remission of metabolic syndrome: through multi-level metabolomics analysis, to clarify the metabolic pathways and mechanisms involved in the process of postoperative remission, and provide a new theoretical basis for the development of tumor metabolic surgery.

Conditions

Metabolic Syndrome; Gastric Cancer

Keywords

Gastric cancer; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Metabolic disease remission

  Metabolic disease remission was defined as any remission of hypertention, diabetes, or fatty liver measured 2 months after surgery. Hypertension remission was defined as arterial blood pressure less than 140/90 mmHg measured postoperatively in patients with preoperative comorbid hypertension. Diabetes remission was defined as fasting blood glucose less than 6 mmol/L measured postoperatively in patients with preoperative comorbid diabetes. Fatty liver remission was defined as liver function in the normal range measured by postoperative blood tests in patients with preoperative comorbid fatty liver.

  From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.

Study Arms (3)

Gastric cancer patients combine with hypertension

Gastric cancer patients diagnosed with hypertension

Diagnostic Test: hypertension

Gastric cancer patients combine with diabetes

Gastric cancer patients diagnosed with diabetes

Diagnostic Test: diabetes

Gastric cancer patients combine with fatty liver

Gastric cancer patients diagnosed with fatty liver

Diagnostic Test: fatty liver

Interventions

hypertension DIAGNOSTIC_TEST

Gastric cancer patients with hypertension

Gastric cancer patients combine with hypertension

diabetes DIAGNOSTIC_TEST

diagnosed with diabetes

Gastric cancer patients combine with diabetes

fatty liver DIAGNOSTIC_TEST

diagnosed with fatty liver

Gastric cancer patients combine with fatty liver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with gastric cancer

You may qualify if:

• \. Age \>18 years old. 2. Patients with hypertension or diabetes for more than 1 year before surgery. 3. Patients undergoing radical gastrectomy for gastric cancer.

You may not qualify if:

• \. Gastric stump cancer. 2. Patients with distant metastasis. 3. Patients who underwent combined resection of other important organs. 4. Severe postoperative complications. 5. Patients who are using drugs that may significantly affect metabolic status (such as hormonal drugs, potent immunosuppressants, etc.). 6. Incomplete clinical data.

Sponsors & Collaborators

• Dong Peng: lead

Study Sites (1)

Chongqing Medical University

Chongqing, Chongqing Municipality, 420006, China

Location

Related Publications (4)

• Cheng YX, Peng D, Tao W, Zhang W. Effect of oncometabolic surgery on gastric cancer: The remission of hypertension, type 2 diabetes mellitus, and beyond. World J Gastrointest Oncol. 2021 Sep 15;13(9):1157-1163. doi: 10.4251/wjgo.v13.i9.1157.

  PMID: 34616520 BACKGROUND

• Nudotor RD, Prokopowicz G, Abbey EJ, Gonzalez A, Canner JK, Steele KE. Comparative Effectiveness of Roux-en Y Gastric Bypass Versus Vertical Sleeve Gastrectomy for Sustained Remission of Type 2 Diabetes Mellitus. J Surg Res. 2021 May;261:407-416. doi: 10.1016/j.jss.2020.12.024. Epub 2021 Jan 27.

  PMID: 33515868 BACKGROUND

• Wang L, Hu D, Fan Z, Yu J, Zhang S, Lin Y, Chen X, Lin X, Yan X, Lin J, Peng F. Prognostic value of long-term antidiabetic and antihypertensive therapy in postoperative gastric cancer patients: the FIESTA study. BMC Gastroenterol. 2022 Oct 9;22(1):429. doi: 10.1186/s12876-022-02514-4.

  PMID: 36210441 BACKGROUND

• Karimi P, Islami F, Anandasabapathy S, Freedman ND, Kamangar F. Gastric cancer: descriptive epidemiology, risk factors, screening, and prevention. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):700-13. doi: 10.1158/1055-9965.EPI-13-1057. Epub 2014 Mar 11.

  PMID: 24618998 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Stomach Neoplasms

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)